Evidence map›Paper›PMID 22391680›Full record

Trial reportNeuroradiology2012

Osteoporotic vertebral compression fracture augmentation by injectable partly resorbable ceramic bone substitute (Cerament™|SPINESUPPORT): a prospective nonrandomized study.

Salvatore Masala, Giovanni Nano, Stefano Marcia, Mario Muto, Francesco P M Fucci, Giovanni Simonetti

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Neuroradiology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02567084 (A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02567084 nacompletednot on this map

A Prospective, Longitudinal Patient Study on CERAMENT™|BONE VOID FILLER in Benign Bone Tumors

TypeinterventionalSponsorPoznan University of Medical SciencesRan2011 to 2014Enrolled14ConditionsBone CystArmsCERAMENT™, BONE VOID FILLER
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 43 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. Review
  8. Radiofrequency ablation of osteoid osteoma.Acta bio-medica : Atenei Parmensis · 2018
    Review
  9. Review
  10. Imaging of pediatric foot disorders.Acta bio-medica : Atenei Parmensis · 2018
    Review
  11. Article
  12. Review
  13. Article
  14. What's new in vertebral cementoplasty?The British journal of radiology · 2016
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Injectable foams for regenerative medicine.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Salvatore MasalaDepartment of Diagnostic and Molecular Imaging, Interventional Radiology and Radiotherapy, University Tor Vergata, Rome, Italy. salva.masala@tiscali.it
Giovanni Nano
Stefano Marcia
Mario Muto
Francesco P M Fucci
Giovanni Simonetti
University of Rome Tor Vergata · ITFatebenefratelli Hospital · ITNuovo Ospedale San Giovanni di Dio · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis study aimed to evaluate long-term stabilizing healing effectiveness and influence on adjacent intact vertebral bodies of a new injectable partly resorbable calcium sulfate (60 wt.%)/hydroxyapatite (40 wt.%) bone substitute employed in vertebral augmentation of osteoporotic collapses.

methodsFrom April 2009 to April 2011, 80 patients underwent vertebral augmentation. Patient enrolment criteria are as follows: age more than 20 years; symptomatic osteoporotic vertebral compression fracture from low energy trauma encompassing level T5 to L1 and classified as A1.1 to A1.2 according to the AO classification system; vertebral height compression within 0-75% compared to the posterior (dorsal) wall; client history confirming the age of the compression fracture to be within at least 4 weeks; and patients who are able to understand the procedure and participate in the study. Preoperative and postoperative imaging studies consisted of computed tomography, plain X-ray, dual X-ray absorptiometry scanning, and magnetic resonance. Pain intensity has been evaluated by an 11-point visual analog scale (VAS), and physical and quality of life compromise assessments have been evaluated by Oswestry Disability Questionnaire (ODI). All procedures have been performed fluoroscopically guided by left unilateral approach under local anesthesia and mild sedation.

resultsVAS-based pain trend over 12-month follow-up has shown a statistical significant (p < 0.001) decrease, starting from 7.68 (SD 1.83) preoperatively with an immediate first day decrease at 3.51 (SD 2.16) and 0.96 (SD 0.93) at 12 months. The ODI score dropped significantly from 54.78% to 20.12% at 6 months. None device-related complication has been reported. In no case, a new incidental adjacent fracture has been reported.

conclusionData show how this injectable partly resorbable ceramic cement could be a nontoxic and lower stiffness alternative to polymethylmethacrylate for immediate and long-term stabilization of osteoporotic collapsed vertebral bodies.

Indexed as

Absorbable ImplantsCeramicsAgedBone SubstitutesCalcium SulfateDrug CombinationsDurapatiteFemaleFractures, CompressionHumansInjectionsMaleOsteoporotic FracturesProspective StudiesSpinal FracturesBone SubstitutesCalcium SulfateceramentDrug CombinationsDurapatite

Identifiers

PMID22391680
OpenAlexW2064007167

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.